System and method for remote monitoring of a user&#39;s vital signs and bodily functions

ABSTRACT

A system and method for comprehensive remote monitoring of a user&#39;s vital signs and bodily functions includes a wearable monitor in bi-directional communication with a gateway element that communicates with one or more external devices to allow remote access to user vital sign and bodily function information.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims benefit of and priority to U.S.Provisional Patent Application Ser. No. 62/643,912 filed Mar. 16, 2018and entitled SYSTEM AND METHOD FOR REMOTE MONITORING OF A USER'S VITALSIGNS AND BODILY FUNCTION, the entire content of which is herebyincorporated by reference herein.

BACKGROUND Field of the Disclosure

The present invention relates to the remote monitoring of a user's vitalsigns and other bodily functions and in particular to a system andmethod for remote monitoring accessible by third parties.

Related Art

Healthcare costs have dramatically risen over the last several years. Inparticular, hospital stays have become more and more expensive making itdifficult for patients who require close monitoring such as thatavailable in a hospital setting to afford this type of care. While somesuch patients can be released to their homes, in order to provide themonitoring they need, it is necessary to provide sometimes equallyexpensive home healthcare providers. Remote monitoring and access to auser's vital signs may also be useful in other areas, such as athletics.

Accordingly, it would be beneficial to provide a system and method forproviding comprehensive monitoring of vital signs and other bodilyfunctions that allows remote access and bi-directional communication.

SUMMARY

It is an object of the present disclosure to provide a method and systemto provide comprehensive monitoring of a user's vital signs and bodilyfunctions. The method and system may be used in-home for a single orlimited number of patients or users or may be provided in an enterpriseenvironment for monitoring a plurality of patients or users. The systemmay also be used to monitor users in other environments as well.

A system to monitor a user's health in accordance with an embodiment ofthe present disclosure includes a monitor element in contact with theuser's body, the monitor element including at least one sensor providinginformation associated with health of the user, the sensor providinginformation associated with one or more of: user heart rate; userrespiration rate; user blood pressure; user oxygen level; a gatewayelement, in wireless communication with the monitor element, wherein theinformation associated with health of the user is received by thegateway element from the monitor element; and a central station incommunication with the gateway element, wherein the informationassociated with health of the user is received by the central stationfrom the gateway element, wherein the central station analyzes theinformation and determines whether intervention is appropriate, based atleast on: at least one heartrate threshold; at least one respirationrate threshold; at least one blood pressure threshold; and at least oneoxygen level threshold.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and related objects, features and advantages of the presentdisclosure will be more fully understood by reference to the following,detailed description of the preferred, albeit illustrative, embodimentof the present invention when taken in conjunction with the accompanyingfigures, wherein:

FIG. 1 illustrates an exemplary block diagram illustrating a system formonitoring a user in accordance with an exemplary embodiment of thepresent disclosure;

FIG. 2 illustrates a schematic representation of the vital signs andbodily functions of the user monitored in the system of FIG. 1 inaccordance with an exemplary embodiment of the present disclosure;

FIGS. 3A, 3B and 3C illustrate an exemplary embodiment of a wearablemonitor suitable for use in the system of FIG. 1 in accordance with anexemplary embodiment of the present disclosure.

FIG. 4 illustrates the wearable monitor of FIGS. 3A-3C including anadhesive element for adhering the monitor to a patient's skin inaccordance with an exemplary embodiment of the present disclosure;

FIG. 5 is a detailed illustration of the adhesive element of FIG. 4 inaccordance with an exemplary embodiment of the present disclosure;

FIG. 5A illustrates an exemplary cross-section of the adhesive elementof FIG. 5 connected to the monitor.

FIG. 6 is an exemplary embodiment of a gateway device used in the systemof FIG. 1 in accordance with an embodiment of the present application;

FIG. 6A illustrates another exemplary embodiment of a gateway deviceused in the system of FIG. 1 in accordance with an embodiment of thepresent disclosure;

FIG. 7 is an exemplary embodiment of a pendant worn by a user and incommunication with the gateway device of the system of FIG. 1 inaccordance with an embodiment of the present disclosure;

FIG. 8 is an exemplary screen shot illustrating an exemplary graphicaluser interface for displaying patient information provided by the systemof FIG. 1;

FIG. 9 is an exemplary screen shot illustrating an exemplary graphicaluser interface for displaying a historical record of certain patientinformation that was provided by the system of FIG. 1;

FIG. 10 illustrates an exemplary embodiment of a charging cradle for usein recharging the monitor of FIGS. 3A-3C;

FIG. 11 is a is an exemplary flow chart illustrating a method formonitoring a user in accordance with an embodiment of the presentdisclosure;

FIG. 12 illustrates an exemplary embodiment of an electrode suitable foruse in the system of FIG. 1;

FIG. 13 illustrates an exemplary in-bed monitor suitable for use in thesystem of FIG. 1;

FIG. 14 illustrates a chart illustrating various fever patterns andcertain diseases associated with those patterns;

FIG. 15 illustrates a table associating fever patters with diseases; and

FIG. 16 illustrates an exemplary placement of the monitor of FIGS. 3A-3Con a user's chest.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The method and system of the present disclosure relate generally tomonitoring user vital signs and other bodily functions for healthcarepurposes. In embodiments, vital signs may include, but are not limitedto heart rate, temperature, oxygen saturation, respiratory rate andblood pressure, to name a few. More specifically, the present disclosurerelates to a system and method for monitoring patient general health andwell-being that allows for monitoring, storing and accessing healthcareinformation remotely. In an embodiment, the system and method of thepresent application may be used to accelerate a patient's return homefrom the hospital by allowing medical professionals to remotely monitorthe patient while not requiring the patient to stay in the hospitalwhich reduces costs and frees up space in hospitals.

In embodiments, the system and method of the present disclosure may alsobe used for other applications. For example, in embodiments, the systemand method of the present disclosure may be used to allow for remoteconsultations with doctors or other health professionals without theneed for a face to face office visit by providing real-time andhistorical information regarding the patient's vitals to the doctor orhealthcare professional remotely. While the vital information is usedherein, the information that is collected and analyzed in the system andmethod disclosed herein may include other health related informationsuch as activity levels, weight and sleep patterns. Alternatively, inembodiments, the system and method of the present application may beused in an enterprise setting, such as a hospital, nursing home orrehabilitation center to monitor and retain records for a large numberof patients.

While the system and method may be used for patients under a physician'scare, in embodiments, it may be used in a wide variety of otherapplications. For example, the ability to remotely monitor a user'svital signs and other bodily functions is may also be useful inathletics. In embodiments, monitoring player vital signs and bodilyfunctions and allowing other parties to access the data allows forplayers to improve training and performance by allowing coaches,trainers, doctors, etc. to access their body's condition during andafter activity. This information may be used to maximize playerperformance and/or to monitor player health after an injury. Inaddition, in embodiments, routine monitoring of vital signs and otherbodily functions may also be useful for users who are in general goodhealth and are not currently under the care of a physician as a means tomaintain good health. In embodiments, routine monitoring of user healthmay be useful in identifying variations in bodily functions or vitalsigns that may be an early sign of disease or disorder such that anysuch problem can be diagnosed or treated early. Early treatment of manydiseases or disorders greatly increases the chances of cure and often atthe very least, minimizes damage to the body. Thus, the method andsystem of the present disclosure may be used by a variety of differentusers in different environments as desired.

In an embodiment, the system 10 of the present disclosure preferablyincludes a wearable monitor 12 that is in wireless communication with agateway device or element 14. FIG. 1 illustrates an embodiment in whicha single patient or user is monitored in a home setting. In anenterprise setting, in embodiments, multiple gateway devices 14 wouldpreferably be provided throughout a hospital or other institution. Inembodiments, multiple monitoring devices or elements 12 may be provided,each one associated with a single patient or user. In embodiments, themultiple gateways 14 may be used to determine a location of a particularpatient or user in the facility based. In embodiments, a location of amonitoring device 12, and the patient associated therewith, may bedetermined by its communication with particular gateway device 14. Inembodiments, the gateway device 14 preferably wirelessly communicateswith external devices and entities, such as a central monitoring station16, for example. In embodiments, the gateway device 14 may alsocommunicate with an emergency call center 18. In an embodiment, thegateway device 14 may also communicate with a clinical monitoring center19. In embodiments, the gateway device 14 sends information to andreceives information or instructions from one or more computing deviceassociated with the central monitoring station 16, emergency call center18 and/or clinical monitoring center 20. In embodiments, the computingdevice may be any desired computing device, including but not limited toa smart phone including a software application including computerexecutable instructions to access and view data in the system 10. Ifdesired, other authorized users 17 may communicate with the gatewaydevice 14 as well. These other users may include individual healthcareproviders, insurance companies or agents thereof and/or family membersof the patient. In embodiments, all communication is bi-directional suchthat the monitor element 12 and the gateway device 14 transmit andreceive information. In an embodiment, communication between the monitor12 and the gateway 14 is wireless and may use any desired protocolincluding radio frequency communication as well as optical and/orultrasonic communication. In a preferred embodiment, the gateway 14communicates using more than one radio frequency to provide forredundancy to external entities. In embodiments, the gateway 14 may alsocommunicate via wire as well with the central monitoring station 16,emergency call center 18 and clinical monitoring center 19. Inembodiments, the gateway 14 may communicate with the central monitoringstation 16, emergency call center 18 and clinical monitoring center 19using any suitable or desired protocol and hardware, including but notlimited to PSTN.

In embodiments, the wearable monitor 12 may include a plurality ofsensor elements that are used to monitor different patient healthfunctions. In embodiments, the monitor 12 may include a plurality ofsensors that gather information sufficient to calculate or otherwisedetermine information indicative of the user's vital signs and otherbodily functions. In embodiments, these calculations may take place inthe monitor 12, in the gateway 14 or in any of the central monitoringstation 16, emergency call center 18 and clinical monitoring center 19.

FIG. 2 illustrates the different categories of vital sign and bodilyfunction information that may be provided based on the informationgathered by the monitor 12. In embodiments, the wearable monitor 12 mayinclude a temperature sensor 20 to provide an indication of thepatient's body temperature. In embodiments, the wearable monitor 12 alsopreferably includes receptacles 20 a, 20 b, 20 c which are connectableto one or more electrodes E (see FIG. 12, for example) that may be usedfor an electro cardiogram (ECG). In embodiments, the wearable monitor 12may also provide blood pressure information 24 as well as a pulseoximetry information 25. In embodiments, mobility information 27 mayalso be provided as an indication of patient mobility. In embodiments,information regarding orientation 28 may be used to indicate thepatient's orientation in bed. In embodiments, sleep quality information29 may be provided as an indication of the patient's quality of sleep.In embodiments, the sensors used to provide this information arepreferably all included in the monitoring device 12 which is connectedto the patient.

In embodiments, the system 10 preferable includes other monitors orsensors as well. In embodiments, a scale 26 may be incorporated into thepatient's bed to provide an indication of the patient's weight, andprovide this information to the gateway 14, either directly or via thewearable monitor 12. In embodiments, the scale 26 may also be used todetermine whether the user is in the bed or not. In embodiments, thescale 26 may be embodied as a conventional scale including a wirelesstransmission element such that it can communicate weight information togateway 14. In embodiments, a heart rate monitor 21 may be provided torecord the patient's heart rate and is preferably provided in the user'sbed. In embodiments, a respiratory sensor 23 is also preferably providedin the user's bed and provides an indication of the patient'srespiratory rate. These components may be provided separately orintegrated together in the in-bed monitoring element 90 discussed below,for example. In embodiments, all of the sensors discussed above provideinformation about the patient that is keyed to a common time code suchthat data regarding all parameters of the user's health at a particulartime can be linked, recorded, viewed and retrieved.

In embodiments, the monitor 12 may be waterproof and is preferablyrechargeable. FIG. 10 illustrates an exemplary recharging cradle 50 inwhich the monitor 12 may be placed for recharging. In embodiments, therecharging cradle 50 may be connected to a power source and also mayinclude a battery such that it can be used to recharge the monitor 12even in the event of a power failure. In embodiments, the monitor 12 mayinclude charging leads (not shown) for connection to the charging cradle50. In embodiments, the monitor 12 may include wireless rechargingfeatures such that it may be recharged when placed in close proximity tothe cradle 50, or simply placed in the cradle 50.

In an embodiment, heart rate, respiratory rate, bed occupancy and sleepmonitoring may also be provided by a separate in-bed monitoring element90. In embodiments, the in-bed monitoring element 90 may be used inaddition to the monitor 12 and transmits information to the gateway 14.In embodiments, the in-bed monitoring element 90 is not in contact withthe patient's body. In embodiments, the in-bed monitoring element 90 mayuse ballistocardiography to sense motion changes of the patient whichmay be used to determine heart rate and respirator rate as well asmotion. In embodiments, the monitor 12 may also be used to gather someof the information gathered by the in-bed monitoring element 90,including at least heart rate and respiratory rate information. Inembodiments, overlapping information collection may be used to improveaccuracy of the monitors 12 and 90 as well as the accuracy of the system10 as a whole.

In embodiments, all of the information gathered, regardless of whetherit is gathered by monitor 12 or monitoring element 90, may be time codedsuch that it may properly correlated when processed to reflect patienthealth at the same time. FIG. 13 illustrates an exemplary embodiment ofthe in-bed monitoring element 90 in which the monitoring elementincludes a sensing portion 90 a and a wireless transmitting portion 90 bto transmit information to the gateway 14.

In an embodiment, each patient or user may be uniquely identified basedon data collected by the wearable monitor 12. In an embodiment, on aninitial use, the monitor 12 may gather information about the user'shealth that is provided to the gateway 14 and used to generate a uniquebody signature for the individual patient. In embodiments, thissignature may be generated by the monitor 12, the gateway 14, or at acentral monitoring station 16. In embodiments, the unique body signaturemay be based on a variety of information gathered by the sensors of themonitor 12 along with other security measures to provide an encryptedsignature unique to the user. In embodiments, once this signature iscreated, it may be stored and each time the monitor 12 is connected to apatient or user, that patient's monitored information will be comparedto the unique signature. In embodiments, if there is no match, an alertsignal may be provided to indicate that there is a problem or possiblefraud. In embodiments, this unique signature may be provided in thecalibration step discussed below.

In an embodiment, the system 10 may also include a pendant device 40(see FIG. 7), preferably worn around the patient's neck. The pendantdevice 40, however, may be worn elsewhere or otherwise carried by thepatient. In embodiments, while the pendant device 40 should always staywith the user, it should be free to move while on the user. In contrast,in embodiments, the wearable monitor 12 is preferable adhered to theuser's skin and stays substantially in the same place while being worn.In an embodiment, the pendant device 40 may include an alert or duressbutton 42 or other indicator that may be activated by the patient whenthey are in duress. In embodiments, activation of this indicatortransmits a duress signal, or alert signal, which is preferably receivedby gateway 14, which in turn contacts the emergency call center 18. Inembodiments, upon receipt of the duress/alert signal, the call center 18may provide emergency assistance and/or may contact a health careprovider or others to intervene. In embodiments, since communicationbetween the gateway 14 and call center 18 is bidirectional, voicecommunication may be established between the call center and the patientsuch that the patient may be interrogated about the cause of distressand a decision may be made about whether intervention is necessary. Inembodiments, the call center 18 may provide emergency assistance bycontacting local police or fire department to send first responders toaid the patient and/or may contact health care providers in the hospitalor home. In embodiments, the call center 18 may also contact thepatient's family members or designated emergency contact, if desired. Inembodiments the decision and communications discussed above may be madeby the central station 16 or the clinical monitoring station 19.

In embodiments, the pendant 40 may include an accelerometer (not shown)which may be used to detect the occurrence of a user fall. Inembodiments, in the event of such a fall, the pendant 40 may alsotransmit the duress/alert signal. In embodiments, the duress/alertsignal may be conveyed to the emergency call center 18 as noted above.In an embodiment, the pendant 40 will communicate with the gateway 14which will then contact the call center 18. In embodiment, the pendant40 may contact the call center 18 directly. The pendant 40 preferablyprovided bidirectional communication to the call center 18, eitherthrough the gateway 14 or directly, for example, to allow the user toconfer with emergency dispatchers and/or medical personnel.

The wearable monitor 12 is illustrated in further detail in FIGS. 3A-3C.In embodiments, the monitor 12 preferably includes electrode receptacles20 a, 20 b and 20 c (see FIG. 3B) that accommodate electrodes E (seeFIG. 3C). In a preferred embodiment, these electrode receptacles areused with “dry electrodes” in that they do not require the use of aconductive gel or other conductive substance to operate. Conventionalelectrodes such as those used for ECG's are usually “wet electrodes” inthat a conductive gel material is applied to the user's skin to ensuregood contact and avoid noise during ECG readings. Unfortunately, theseconductive gels and other materials are not suitable to remain on thepatient's skin for long periods of time since the salts in thesematerials have a tendency to irritate skin. Since monitor 12 is intendedto be worn substantially constantly by a patient for long periods oftime, wet electrodes are simply not a good option, although, it is notedthat wet electrodes may be be used with the monitor 12 as well. In apreferred embodiment, upon application of the monitor 12 to a user'sskin, the device performs a test to determine whether the preferred dryelectrodes are in use. If not, an alert is issued.

In embodiments, the wearable monitor 12 may be designed to allow fordesired positioning of the electrode receptacles 20 a, 20 b and 20 c(and the electrodes positioned therein) to provide accurate ECG results.In addition, the body of the monitor 12 may be designed to provide forrelative comfort while providing opportune placement of the electrodesE. In embodiments, the monitor 12 preferably includes a main portion 12a and a smaller secondary portion 12 b spaced apart from the mainportion on an opposite end thereof. In embodiments, the main portion 12a and secondary portion 12 b are connected to each other by a narrow andsomewhat flexible bridge portion 12 c. In embodiments, as a result, inembodiments, the electrode receptacles 20 a, 20 b and 20 c may bepositioned at a desired spacing while the somewhat flexible connectionbetween the main portion 12 a and secondary portion 12 b allows forcomfort as the user moves around during the day. In embodiments, thebridge portion 12 c is somewhat flexible and not attached directly tothe user's skin which increases comfort for the user such that the mainportion 12 a and secondary portion 12 b are movable with the user's skinwhile the bridge 12 c provides flexibility.

The main portion 12 a and secondary portion 12 b are directly connectedto the user's skin via adhesive element 60. In an embodiment, theadhesive element 60 may include a main part 60 a and a smaller secondarypart 60 b. In embodiments, the main part may have an open center regionand extends beyond a periphery of the main portion 12 a of the monitor12. In embodiments, the secondary part similarly has an open centerportion and extends beyond a periphery of the secondary portion 12 b, ascan be seen in FIG. 4, for example. In embodiments, the adhesive element60 preferably includes a lower layer of adhesive that is connected to auser's skin that is hypoallergenic and is preferably made of cloth orsilicone, which tend to be less abrasive to skin and add comfort. Inembodiments, another adhesive layer may be provided over the lower layerand connects to the monitor 12 which need not be hypoallergenic and maybe of any desired material as it does not contact user skin. Inembodiments, these multiple layers are visible in the cross-sectionalview of FIG. 5A, for example. While FIG. 5A indicates specific productsused in the layers, any suitable materials may be used. In embodiments,an applicator A may be provided to guide placement of the adhesiveelement 60 on the monitoring device 12. While the monitor 12 ispreferably adhered to the user's skin, in an embodiment, the monitor 12may be incorporated into fabric or an article of clothing and held nextto the user's body. In such an embodiment, the adhesive element 60 maynot be necessary. FIG. 16 illustrates an exemplary positioning of themonitor 12 on a user's chest. FIG. 16 also indicates the various leadplacement locations V1, V2 . . . V6 used in conventional ECGs.

In embodiments, in order to ensure good contact with the user's skin,the receptacles 20 a, 20 b and 20 c are mated with a “dry electrode” asnoted above that include a surface with a plurality of raised bumps tocontact the user's skin. FIG. 12 illustrates an example of such a dryelectrode in which this surface is visible. In embodiments, thereceptacles 20 a, 20 b and 20 c, and thus the electrodes E mountedtherein, are preferably positioned in alignment with the open portionsof the adhesive element 60 such that they can contact the skin of thepatient when the monitor 12 is adhered in place on the patient's body.In embodiments, where the monitor 12 is held in place using clothing, anopening may be provided in the clothing to allow the electrodes E in thereceptacles 20 a, 20 b and 20 c to contact the user's skin.

In an embodiment, the monitor 12 may include one or more LEDs 35 thatare positioned to face the patient when the monitor is in contact withthe patient. In a preferred embodiment, a red LED and an infrared LEDare included as well as a light meter to detect reflected light from theLEDs. In embodiments, the LEDs 35 and light meter may be used todetermine various parameters, including blood pressure, SPO2 and heartrate (pulse). In embodiments, blood pressure estimation may bedetermined based on pulse transit time (PTT), the interval between thepeak of the R-wave in electrocardiogram (ECG) and the photoplethysmogram(PPG) measured elsewhere, which is related to arterial stiffness, andcan be used to estimate the systolic blood pressure (SBP) and diastolicblood pressure (DBP). In embodiments, the pulse measurement may beobtained based on the use of reflected light from the LEDs. Inembodiments, the pulse information in a conventional PTT calculation isgathered at the user's heart and second pulse information is gathered ata finger or other extremity. In the present application, the secondpulse location may be in the proximity of the heart and chest as wellsince the monitor 12 must be positioned in that area to provide anaccurate ECG. In embodiments, reflection of light from the LEDs 35 a isused to determine pulse at the heart and spaced from the heart. In anembodiment, a modified PTT calculation is provided for estimating bloodpressure in view of the close proximity of the two pulse points. Inembodiments, this calculation may be performed by the monitor 12, thegateway 14 or elsewhere, such as the central processing location 16.Naturally, in embodiments, the LEDs 35 a may be used to determine pulseof the patient as well. In addition, in embodiments, a thermistor 35 bmay be used to determine patient skin temperature.

In embodiments, the LEDs 35 a are used to determine PPG of the patient.In this application, a modified algorithm is also used to allow forpatients with darker skin color. PPG uses the amount of light reflectedand those with darker skin colors may not reflect sufficient light suchthat the algorithm is modified to adjust for this.

In embodiments, the system 10 may also be used to determine the locationor proximity of a patient. For example, as noted above, in embodiments,in an enterprise environment where multiple gateway devices 14 arepositioned throughout a facility, patient proximity and location may bedetermined based on communication with a particular gateway device. Inaddition, in embodiments, nurses or other healthcare personnel may carrymonitors 12, or variations thereof to track their interaction withparticular patients based on their relative position. In embodiments,this may be used in order to ensure compliance with medication andtherapy schedules.

In an embodiment, mobility information or proximity information may beused to determine the status of the patient, i.e. resting, walking,running etc. In embodiments, this information may be combined withinformation on the user's vitals to provide a more useful context forthe patient information. For example, an elevated heart rate or bloodpressure may not be a cause for alarm if the patient has just walked upa flight of stairs whereas it may be a danger sign if the patient is andhas been laying still for some time. Thus, in embodiments, the state ofthe user is recorded along with the vitals. In embodiments, all of thisinformation is preferably provided to the central monitoring station 16and preferably to the clinical monitoring station 19. The clinicalmonitoring station 19 is typically a computing device provided in ahospital or other healthcare facility that analyzes informationregarding the patient as would be the case if the patient were in thehospital. In embodiments, where the patient information indicates thatthe patient may be under duress, an alert may be generated and sent tohealthcare providers, family members or emergency contacts. Inembodiments, the clinical monitoring station 19 may make decisions basedon current information and/or historical information and may alsocontact the emergency call center 18 to send an alert signal which isacted on as described above. In embodiments, the decisions discussedabove may be made by the central station 16 or clinical monitoringstation 19.

In embodiments, the gateway 14 and monitoring device 12 communicate witheach other via bidirectional radio communication such that the devicesends data to the gateway and the gateway can send data or instructionsto the device 12. In embodiments, the wireless communication between thegateway 14 and monitoring device 12 may be via light or sound, forexample, using ultrasonic communication. In an embodiment, the gateway14 may be programmable with a predetermined test such that a series ofmeasurements may be initiated by pressing a single button or receiving asingle command. In embodiment, the single command may be provided by thecentral station 16, for example. Similarly, in embodiments, the monitor12 may be preprogrammed in such a manner. In embodiments, the monitor 12may be programmed to perform desired measurements based on a commandreceived from the central station 16, via the gateway 14. Inembodiments, the gateway device 14 also communicates via radiofrequency, other wireless communication system or a wired connectionwith the emergency call center 18, the central monitoring station 16 andclinical monitoring station 19 and allows two way communication suchthat the gateway can transmit information and can receive informationand instructions. The gateway 14 may receive commands regarding takingcertain measurement from the central station 16, for example. Thesecommands may be executed by the gateway 14 or passed on to the monitor12, as appropriate. In embodiments, the bidirectional communicationbetween the gateway and the central station and/or between the gatewayand the monitor 12 may be used to update firmware operating in themonitor or the gateway 14. In embodiments, as illustrated, in apreferred embodiment, data may be saved in a cloud setting, however, thedata may be saved in any suitable storage element. In embodiments, thegateway 14 may include a display (see FIG. 6A, for example) thatillustrates information regarding the user's vital signs or other bodilyfunctions. In embodiments, data that is gathered by the monitor 12 maybe checked or verified for errors or corruption before it is transmittedto the gateway 14 and/or the central station 16. If the data is flawed,in embodiments, it will not be transmitted. Similarly, in embodiments,data at the gateway 14 may be checked for errors or corruption before itis transmitted to either the monitor 12 or the central station 16 (oremergency call center 18 or clinical monitoring station 19). Inembodiments, flawed data is not transmitted to avoid wasting resourceson flawed data.

In embodiments, the central station 16 may include at least onecomputing device operably connected to at least one memory element andmay store and archive data. In addition, the computing device of thecentral station 16 includes one or more processors that provide analysisof data including but not limited to the generation of predictive modelsbased on past information for a patient. In embodiments, the data may beviewed by users at the central station 16, at the call center 18 or atthe clinical monitoring center 19. In embodiments, the call center 18and the clinical monitoring center 19 may include one or more computingdevices operably connected to one or more memory devices. The computingdevices also include one or more processors that may be used to processinformation received and to allow access thereto. In a preferredembodiment, specific users may select the information that they wish toview. In embodiments, information may be viewed in real time, orpresented as part of a historical record or both. FIG. 8 illustrates anexemplary screen shot of a graphical user interface usable by a user toview certain patient information. FIG. 9 similarly illustrates anexemplary screen shot of a graphical user interface displayinghistorical data regarding a patient.

In an embodiment, the information provided by the monitoring device 12and transmitted by the gateway device 14 is stored and analyzed toprovide a vitality score. In embodiments, this may be done at themonitoring device 12, the gateway device 14, the central station 16, thecall center 18 and/or the clinical monitoring center 19. In embodiments,the vitality score may generated based on the information regardingvital functions of the patient monitored by the monitoring device 12with a higher vitality score assigned to patients with desirableresults. In embodiments, patient's whose vital functions are observed tobe in desirable ranges will be assigned higher vitality scores. Inaddition, certain functions may be weighted, if desired, to have more orless influence over the vitality score. In embodiments, this calculationis preferably done in the central station 16, but may be done elsewherein the system 10.

FIG. 11 illustrates an exemplary flow chart for a method of monitoring apatient. In embodiments, in step S100, a monitoring element is attachedto the patient's skin. In embodiments, in step S101, the monitoringelement may provide information indicating various vital functions andother health related information of the patient. In embodiments, in stepS102, the information indicating various vital functions of the patientis transmitted to an external monitoring element. In embodiments, instep S103, the external monitoring element may assess or otherwiseanalyze the information indicating various vital functions of thepatient to determine whether the patient is in distress. In embodiments,this analysis may also take place locally at the monitor 12, gateway 14,central station 16, call center 18 and/or clinical monitoring center 19.In embodiments, if distress is determined, an alert signal may begenerated and intervention may be requested. In embodiments, in stepS104, the information indicating various vital functions of the patientmay saved in a storage element or any suitable memory element. Inembodiments, all of the information may be time stamped such thatinformation regarding different patient functions may be matched toother information from the same time to provide an accurate snapshot ofthe patient's health at that time.

In embodiments, a calibration step may be provided after step S100 inwhich the monitoring element 12 and system 10 are calibrated. Inembodiments, calibration may be accomplished by comparing measured orcalculated values of the system 10 to values that are obtained using socalled gold standard devices. In embodiments, the term “gold standarddevice(s)” generally refers to traditional devices used to measure bodyfunction. For example, with respect to blood pressure, a traditionalblood pressure cuff is a gold standard device. In an embodiment, thecuff may be automated and provided with a transmission device such thatthe measured values thereof are transmitted to the monitor 12, gatewaydevice 14, central monitoring center 16 or the clinical monitoringcenter 19 where they may be recorded and compared to measured orcalculated values provided via the monitor 12 or other sensors in orderto fine tune the system 10. Alternatively, in embodiments, bloodpressure may be manually measured by a healthcare professional with theresults may be either transmitted from a personal electronic device orotherwise input by the healthcare provider. In embodiments, anotherexample of a “gold standard device” would be a thermometer for use indetermining body temperature. In embodiments, this may be automated in amanner similar to that discussed above with respect to the bloodpressure cuff or may be provided by intervention of a healthcareprovider. In embodiments, the values measured by such gold standarddevices are compared to the measured or calculated values determined bythe system 10 to test the accuracy of the system. In embodiments, wherethere is a discrepancy, the system 10 may be modified to provide forbetter accuracy and/or the monitor 12 may be repositioned to providebetter results. In embodiments, while a blood pressure cuff andthermometer are identified herein as “gold standard devices,” it shouldbe understood that there are many other devices that would be consideredgold standard devices and this term is not limited to these two examplesbut includes any devices that are customarily and traditionally reliedon by healthcare providers to gather information about patients andtheir body functions. In embodiments, these devices may be automated, assuggested above, or may be used manually by healthcare providers inorder to properly calibrate the system 10. In embodiments, thecalibration step discussed above may be repeated periodically, asdesired, to maintain accuracy of the system 10. It is noted that thecalibration step should always be executed when the monitor 12 is beingused in conjunction with a new patient.

In an embodiment, the monitoring element in step S101 is the monitoringelement 12 discussed above. In an embodiment, after step S101, theinformation indicating various vital functions of the patient may betransmitted from the monitoring element 12 to the gateway device 14discussed above. In embodiments, the gateway device 14 may be used tocomplete step S102. In embodiments, the external monitoring element maybe embodied by any of the central monitoring center 16, the emergencycall center 18 or the clinical monitoring center 19 which may processthe information indicating various vital functions of the patient asdescribed above. In embodiments, the monitoring element of step S101 mayinclude the in-bed monitoring element 90.

In embodiments, as noted above, one or more LEDs 35 a on the element maybe used to determine PPG, pulse, and blood pressure as part of stepS101, if desired. Other patient information may be provided via othersensors, such as the thermistor 35 b and others discussed above.

In embodiments, if desired, as noted above, a step of establishing aunique signature of the user may be provided after step S101 or stepS102 or as part of the calibration step discussed above. Further,following the storage step of S104, in embodiments, the storedinformation may be accessed for further processing. In an embodiment,the stored information may be used to make predictive calculationsregarding user vitals. For example, past data regarding vital signs maybe useful in predicting and diagnosing diseases or disorders. FIG. 14illustrates various fever patterns and indicates diseases that tend toresult in such patterns. FIG. 15 illustrates a table describing some ofthese patterns and identifying diseases consistent with them.Accordingly, the stored information regarding user vital signs such asbody temperature, for example, may be analyzed over a period of time topredict or help diagnose a particular disease of the user. While bodytemperature is discussed above, patterns may be identified with respectto other patient attributes which may also allow for prediction ordiagnosing of disease. In embodiments, the stored information may beused for predicting and diagnosing disease by the central monitor 16,emergency call center 18 or the clinical monitoring center 19.

In addition, the stored information may be used to provide a vitalityscore, as mentioned above. In embodiments, the vitality score may beused to indicate a general trend in patient health, i.e. improving,degrading or neutral based on the information provided by the system.

The transmitted information may also be analyzed to determine whetherintervention is required to aid the user. For example, in the event thatthe transmitted information includes a duress signal, as discussedabove, an additional step of summoning intervention may be added.Alternatively, or in addition, a step of communicating with the user byvoice may be added to check on the user's status before summoningintervention. In another embodiment, in the event that the transmittedinformation indicates that the user is in distress, i.e. dangerously lowor high heart rate, blood pressure, pulse, body temperature, lack ofmobility for an extended period of time etc., a decision may be made tosummon intervention. In embodiments, these decisions may be made at theemergency call center 18, either automatically or based on humanintervention, the clinical monitoring center 19 or the centralmonitoring center 16.

Although the present invention has been described in relation toparticular embodiments thereof, many other variations and modificationsand other uses will become apparent to those skilled in the art. Stepsand units described in relation to one aspect of the method or systemmay be added, or substituted, for steps or units described with respectto another aspect of the system. Combinations and permutations of stepsdifferent from those outlined are also contemplated. Steps outlined insequence need not necessarily be performed in sequence, not all stepsneed necessarily be executed, and other intervening steps may beinserted. It is preferred, therefore, that the present invention belimited not by the specific disclosure herein.

What is claimed is:
 1. A system to monitor a user's health comprising: amonitor element in contact with the user's body, the monitor elementincluding at least one sensor providing information associated withhealth of the user, the sensor providing information associated with oneor more of: user heart rate; user respiration rate; user blood pressure;user oxygen level; a gateway element, in wireless communication with themonitor element, wherein the information associated with health of theuser is received by the gateway element from the monitor element; and acentral station in communication with the gateway element, wherein theinformation associated with health of the user is received by thecentral station from the gateway element, wherein the central stationanalyzes the information and determines whether intervention isappropriate, based at least on: at least one heartrate threshold; atleast one respiration rate threshold; at least one blood pressurethreshold; and at least one oxygen level threshold.
 2. The system ofclaim 1, wherein the information associated with the health of the useris stored in a memory associated with the central station.
 3. The systemof claim 1, wherein the information associated with the health of theuser further comprises information associated with: user weight; useractivity; and user sleep quality.
 4. The system of claim 1, wherein themonitor element comprises an adhesive element positioned on an innersurface thereof for contact with the user's skin to position the monitorelement on the user's body.
 5. The system of claim 4, wherein theadhesive element includes an alignment element positioned to aid inpositioning of the monitor element on the user's body.
 6. The system ofclaim 1, wherein the monitor element comprises a plurality ofelectrodes.
 7. The system of claim 6, wherein a pair of electrodes areprovided on a first end of the monitor element and a third electrode isprovided on a second end of the monitor element, opposite the first end.8. The system of claim 7, wherein the pair of electrodes are providedside by side.
 9. The system of claim 8, wherein the third electrode isspaced a predetermined distance from the pair of electrodes.
 10. Thesystem of claim 9, wherein the pair of electrodes and third electrodeare positioned to provide ECG information.
 11. The system of claim 7,wherein the first end of the monitor element is connected to the secondend of the monitor element via a flexible bridge element such that thefirst end of the monitor element and second end of the monitor elementare movable with the user's skin relative to each other.
 12. The systemof claim 1, wherein the monitor element further comprises an in-bedmonitoring element.
 13. The system of claim 10, wherein the monitorelement comprises at least one light emitting diode and at least onelight sensor facing the user.
 14. The system of claim 13, wherein the atleast one light sensor provides light sensing information based on lightreflected from the at least one light emitting diode off the user'sskin.
 15. The system of claim 14, wherein the light sensing informationand ECG information are used to determine the user blood pressure. 16.The system of claim 14, wherein the light sensing information and ECGinformation is transmitted from the monitor element to the gatewayelement and the user blood pressure is determined at the gatewayelement.
 17. The method of claim 14, wherein the light sensinginformation and ECG information is transmitted from the monitor elementto the gateway element and from the gateway element to the centralstation and the user blood pressure is determined at the centralstation.
 18. The system of claim 1, further comprising an alert devicein wireless communication with at least one of the gateway element andthe central station.
 19. The system of claim 18, wherein the alertdevice comprises an alert button, wherein the alert device transmits analert signal to the gateway element when the alert button is actuatedand the gateway element transmits the alert signal to the centralstation.
 20. The system of claim 19, wherein the gateway elementtransmits the alert signal to emergency personnel.
 21. The system ofclaim 19, wherein central station transmits the alert signal toemergency personnel.
 22. The system of claim 16, wherein the alertdevice provides two way communication with at lease one of the gatewayelement and the central station.
 23. The system of claim 1, furthercomprising a bed sensor in wireless communication with the gatewayelement.
 24. The system of claim 23, wherein the bed sensor providesorientation information associated with a position of the user in a bed.25. The system of claim 24, wherein the orientation information is usedby the gateway element to provide mobility information associated withthe user.
 26. The system of claim 24, wherein the orientationinformation is used by the gateway element to provide sleep activityinformation associated with the user.
 27. The system of claim 24,wherein the orientation information is transmitted by the gatewayelement to the central station and the central station provides mobilityinformation associated with the user.
 28. The system of claim 24,wherein the orientation information is transmitted by the gatewayelement to the central station and the central station provides sleepactivity information associated with the user.
 29. The system of claim1, wherein the monitor element checks the information associated withhealth of the user for errors prior to sending the informationassociated with health of the user to the gateway element and does notsend the information associated with health of the user to the gatewayelement when errors are detected.
 30. The system of claim 1, wherein thegateway element checks information received from the monitor element forerrors before transmitting to the central station and checks datareceived from the central station for errors before transmitting it tothe monitoring device, and does not transmit data when errors aredetected.
 31. The system of claim 1, wherein the monitoring device is intwo way communication with one or more of the gateway device and thecentral station.